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Active ingredients
Valaciclovir
Release form
Pills
Composition
1 tablet contains: Active substance: valaciclovir hydrochloride hydrate 611.7 mg, which corresponds to the content of valaciclovir 500 mg. Auxiliary substances: microcrystalline cellulose - 59.6 mg, povidone K30 - 24.5 mg, magnesium stearate - 4.2 mg. Composition of the film shell: white Y-5 opadry -7068 (hypromellose 3cP - 7.35 mg, hyprolosis - 6.3 mg, titanium dioxide - 4.2 mg, macrogol / PEG 400 - 2.1 mg, hypromellose 50cP - 1.05 mg) - 21 mg.
Pharmacological effect
Once in the human body, valaciclovir turns into acyclovir and L-valine. Aciclovir is active against viruses by destroying their DNA. Patients with severe immunity disorders (receiving chemotherapy, HIV-infected, patients with bone marrow transplant), viruses have decreased sensitivity to valacyclovir.
Pharmacokinetics
Valacyclovir is rapidly absorbed from the gastrointestinal tract. Aciclovir, which is formed after valaciclovir is ingested, is distributed in the lungs, muscles, liver and kidneys. It also enters the cerebrospinal fluid, the secret of the vagina and the fluid of herpetic vesicles. Valaciclovir is excreted from the body through urine.
Indications
Labile herpes therapy; herpes zoster therapy; prevention and treatment of recurrent infections of mucous membranes and skin caused by the herpes simplex virus; has an effect on preventing cytomegalovirus infection that occurs during organ transplantation; reduces infection of a healthy partner with genital herpes.
Contraindications
The drug is not recommended for use in kidney and bone marrow transplantation; in severe HIV infection; in the presence of individual intolerance to the components of the drug; children's age up to 12 years.
Use during pregnancy and lactation
Experience in the use of the drug during pregnancy is not enough. Appointment of valacyclovir is recommended only when the therapeutic effect for the mother is higher than the possible risk to the fetus. Metabolite Valvira - acyclovir - is excreted in breast milk. Breastfeeding is allowed only when the effect of treatment for the mother is significantly higher than the perceived risk to the child.
Dosage and administration
The drug is intended for oral administration, prescribed only for adults with the following diseases: herpes zoster - a course of treatment for 7 days to 1 oz. 3 times a day. Simple herpes - 0.5 gr. 2 times a day. Relapses require a course of treatment in 3-5 days. If the therapy is carried out for the first time, the duration of the drug intake should be up to 10 days. Biliary herpes - the therapy should be carried out according to the following scheme: 1 day - 2 g 2 times, the next dose is taken after 12 hours. Prevention of recurrence of infections caused by the herpes simplex virus - when immunity is preserved, it is prescribed 0.5 g once a day; with frequent relapses (10 times a year or more), 0.25 g 2 times a day is prescribed; with immunodeficiency prescribed 0.5 g 2 times a day. The duration of treatment is from 4 to 12 months. Prevention of infection of a healthy partner with genital herpes - if a heterosexual adult is infected who has preserved immunity and the number of exacerbations 9 times a year, then 0.5 g is administered once a day for a year. With regular sex life, the drug should be taken every day. If sex is irregular, Valvir should be taken 3 days before the intended sexual contact. Prevention of cytomegalovirus infection - adolescents from 12 years old and adults are prescribed 2 g 4 times a day (treatment should begin immediately after transplantation). Duration of treatment is 90 days. In patients at high risk, therapy may be longer. Dosing of the drug also depends on the creatinine clearance (CC). Patients who undergo hemodialysis should start taking the drug as soon as possible after the procedure. If the patient has moderate or poorly cirrhosis of the liver while maintaining the synthetic function, no dosage adjustment of the drug is required. There is no need to adjust the dose and in severe liver cirrhosis. But it should be borne in mind that experience with this pathology is limited. In old age, dose adjustment is not required. The exception is a significant impaired renal function.
Side effects
The most common adverse reactions are nausea and headache. Serious side effects include neurological disorders, acute renal failure,thrombocytopenic purpura, uremic syndrome. From the lymphatic system and blood: thrombocytopenia and leukopenia. From the digestive system: discomfort or abdominal pain, nausea, vomiting, diarrhea. From the psyche and nervous system: aggressive behavior, confusion, dizziness, decrease intellectual abilities, hallucinations. Very rarely, tremor, agitation, dysarthria, ataxia, depression, mania, coma, encephalopathy, convulsions are possible. These symptoms are reversible and occur in patients with kidney disease. On the immune system: anaphylaxis. On the subcutaneous tissue and skin: itching, rash. On the respiratory system: dyspnea. On the urinary system: renal dysfunction, renal colic, acute renal failure. Allergic reactions: angioedema, urticaria. Also impaired vision, decreased hemoglobin, anemia, increased blood pressure, swelling of the face, respiratory infections, fatigue, tachycardia.
Overdose
Information on overdose with valaciclovir is currently insufficient. When a drug is consumed in doses exceeding the therapeutic norm, the following symptoms of overdose may appear: if a single dose is higher than the norm up to 20 g, then the drug does not have a toxic effect; if an ultra-high dose is taken several days, then the head pain, nausea, vomiting, confusion. In case of overdose, symptomatic treatment is necessary.
Interaction with other drugs
During clinical studies, no significant interaction was found.
special instructions
With the occurrence of side effects from the central nervous system (delirium, hallucinations, convulsions), the drug should be discontinued. In the presence of renal insufficiency, the risk of neurological complications increases. Dosage correction of the drug can be avoided with moderate or weak liver cirrhosis and other liver dysfunction. Also, do not require dose adjustment in elderly patients. Elderly patients with significant impaired renal function are an exception. There is no clinical experience with valacyclovir in pediatrics. If there are side effects of the medication associated with psychomotor reactions, then you need to be careful when driving motor vehicles and controlling mechanisms.